In its June 13, 2013 opinion in Association of Molecular Pathology et al. v. Myriad Genetics, Inc. et al., the Supreme Court held that isolated DNA is not patent eligible merely due to its isolation and that cDNA is patent eligible because it does not occur naturally.  The Court reversed the Federal Circuit's holding that isolated DNA is patent eligible and affirmed that cDNA is patent eligible. Assoc. for Molecular Pathology v. Myriad, 569 U.S. ___ (2013) at 8, 18.  The Patent and Trademark Office promptly sent a letter to its Examiners the same day directing the Examiners to “reject product claims drawn solely to naturally occurring nucleic acids and fragments thereof, whether isolated or not”.  June 13, 2013 letter from Deputy Commissioner Hirschfeld to Patent Examining Corps.

Myriad Genetics, Inc. (“Myriad”) obtained a number of patents.  At issue in the case were nine composition claims from three of the patents, claims 1, 2, 5, 6 of U.S Pat. No. 5,747,282, claim 1 of U.S. Pat. No. 5,693,473, and claims 1, 6, and 7 of U.S. Pat. No. 5,837,492.

The Court in Myriad stated “genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.”  Myriad, 569 U.S. at 18.  Furthermore, the Court held “cDNA is not a product of nature and is patent eligible” except for very short sequences with no introns that are identical to the natural DNA.  Id. at 17.

The Court stressed that the decision did not implicate method claims, patents on new applications of knowledge regarding the genes in question, and patentability of DNA in which the order of the sequence has been changed. Id. at 17-18.  The opinion may cause consideration of the patentability of various types of molecules.

Due to degeneracy of the genetic code, an amino acid is encoded by various codons with the third base in the codon able to vary.  The opinion states “[n]or do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.”  Id. at 18.  However, claim 1 states “1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.”  U.S Pat. No. 5,747,282 at claim 1.  A DNA sequence coding for the BRCA1 polypeptide of the sequence in SEQ ID NO:2 could have a different DNA sequence than the naturally occurring BRCA1 DNA sequence.  The Federal Circuit stated that “[i]solated DNA . . .is a free-standing portion of a larger, natural DNA molecule.”  It is likely that a DNA sequence having mutations at the third position of various codons would be patent eligible.

Recombinant DNA from genomic DNA is unlikely to be patent eligible if the sequence is the same as the naturally occurring sequence.  However, if any chemical differences were incorporated in the recombinant DNA, the molecule may be patent eligible.

Fusion proteins using portions of naturally occurring and non-naturally occurring sequences fused together are likely to be patent eligible due to the presence of non-naturally occurring sequences.  The Court found that cDNA, containing a portion of the naturally occurring DNA sequence (exons), but not introns, was patent eligible. Id. at 17.  Further, the Court stated “[t]he possibility that an unusual and rare phenomenon might randomly create a molecule similar to one created synthetically through human ingenuity does not render a composition of matter nonpatentable.”  Id. at 16, n. 8.  Therefore, a rare occurrence of the sequence of the fusion protein in nature would not make the fusion protein ineligible to be patented.

Naturally occurring bacterial DNA which does not contain introns likely would not be patent eligible.  The opinion states “[a]s a result, cDNA is not a ‘product of nature' and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA.  In that situation a short strand of cDNA may be indistinguishable from natural DNA.”  Id. at 17.

It remains to be seen whether this holding will affect the patentability of other isolated or purified products of nature such as therapeutic purified from a natural source.  The holding in the present case was limited to naturally occurring DNA but purified chemical composition such as prostaglandin and adrenaline have been found to be patent eligible. In re Bergstrom, 427 F.2d 1394, 1401-02 (C.C.P.A. 1970) (pure prostaglandin is not a natural substance and is patent eligible); Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95, 103 (C.C.S.D.N.Y. 1911) (purified adrenaline was found to be patent eligible).

Justice Scalia wrote a concurrence in part and in the judgment to the opinion written by Justice Thomas and joined by Chief Justice Roberts and Justices Kennedy, Ginsburg, Breyer, Alito, Sotomayor, and Kagan.  In his concurrence, Justice Scalia noted that he joined in the opinion with the exception of the portions going into fine details of molecular biology which he was unable to affirm based on his own knowledge or belief.  Id. at 19.